RECRUITING

Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter

Conditions

Glioblastoma, IDH-wildtype radiotherapy radiation sensitizing agent ropidoxuridine unmethylated MGMT promoter

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.

Official Title

Phase 2 Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients With Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter

Quick Facts

Study Start:2024-09-02

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06359379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Written informed consent form signed and dated by patient or legally authorized representative according to local guidelines, prior to the performance of any study-specific procedures, sampling, or analyses. Participants with impaired decision-making capacity must have a close caregiver or legally authorized representative present. * Histologically confirmed supratentorial glioblastoma isocitrate dehydrogenase (IDH) wild-type classification (2021 World Health Organization Classification of Tumours, 5th Edition, Volume 6) with unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoter (defined as MGMT methylation status ≤20% by pyrosequencing, and no prior radiation, electric field, or systemic therapy. Glucocorticoid therapy for symptom control is allowed. * Patients should, in the opinion of the investigator, be candidates for 60 Gy radiotherapy in 2 Gy fractions over 6 weeks, per standard of care. Hypofractionated radiotherapy schedules (e.g., 36 Gy in 3 Gy fractions) are not allowed. * Eastern Cooperative Oncology Group performance status of 0, 1 or 2. * Adequate renal, liver and bone marrow function: * Hemoglobin \>9.0 g/dL * Absolute neutrophil count \>1.5 × 10\^9/L * Platelet count \>100 × 10\^9/L * Total bilirubin ≤1.5 × upper limit of normal (ULN), unless due to documented Gilbert's disease (≤3 × ULN) * Aspartate aminotransferase / alanine aminotransferase ≤4×ULN * Creatinine clearance ≥60 mL/min calculated as per Cockcroft-Gault equation. * Life expectancy ≥12 weeks. * Have recovered from the immediate post-operative period and is maintained on a stable corticosteroid regimen (no increase for 5 days) prior to initiation of study treatment. * Female patients, of childbearing potential, must have a negative serum pregnancy test within 7 days prior to taking study medication and agree to use at least one highly effective form of contraception during study treatment and for at least 120 days after the last dose of study treatment. * Male patients must agree to use an adequate method of contraception from enrollment through 120 days after the last dose of study treatment.	* Any prior treatment for glioblastoma, including chemotherapy, immunotherapy, targeted therapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, lymphokine-activated killer cell therapy or gene therapy), or radiotherapy. Glucocorticoid therapy is permitted. * Second primary malignancy expected to require active treatment within a 6-month period (except basal cell or early-stage squamous cell carcinoma of the skin that may be excised). Patients who had another malignancy in the past but have been free of active disease for more than 1 year, are eligible even if under active surveillance, at the discretion of the Investigator. Adjuvant anti hormonal treatment for prior breast or prostate cancer is allowed, but no other concomitant anticancer treatment. * Any investigational therapy (for any concomitant condition) within 28 days or within 5 half-lives of study entry (whichever is shorter). * Use of acid-reducing agents including proton pump inhibitors and histamine-2 blockers. * Inability to comply with protocol or study procedures. * Women who are pregnant or breastfeeding. * Inability to swallow oral medication or gastrointestinal disorder expected to severely affect drug absorption (e.g., short bowel syndrome). * Ongoing bacterial, viral, or fungal infection requiring systemic therapy. Prophylactic therapy is allowed. Patients with a history of Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus infection are allowed if treated with effective anti-viral therapy that results in undetectable viral load. * Any medical condition, which in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities, or makes the patient unsuitable for study participation.

Inclusion Criteria

Exclusion Criteria

* Written informed consent form signed and dated by patient or legally authorized representative according to local guidelines, prior to the performance of any study-specific procedures, sampling, or analyses. Participants with impaired decision-making capacity must have a close caregiver or legally authorized representative present.
* Histologically confirmed supratentorial glioblastoma isocitrate dehydrogenase (IDH) wild-type classification (2021 World Health Organization Classification of Tumours, 5th Edition, Volume 6) with unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoter (defined as MGMT methylation status ≤20% by pyrosequencing, and no prior radiation, electric field, or systemic therapy. Glucocorticoid therapy for symptom control is allowed.
* Patients should, in the opinion of the investigator, be candidates for 60 Gy radiotherapy in 2 Gy fractions over 6 weeks, per standard of care. Hypofractionated radiotherapy schedules (e.g., 36 Gy in 3 Gy fractions) are not allowed.
* Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
* Adequate renal, liver and bone marrow function:
* Hemoglobin \>9.0 g/dL
* Absolute neutrophil count \>1.5 × 10\^9/L
* Platelet count \>100 × 10\^9/L
* Total bilirubin ≤1.5 × upper limit of normal (ULN), unless due to documented Gilbert's disease (≤3 × ULN)
* Aspartate aminotransferase / alanine aminotransferase ≤4×ULN
* Creatinine clearance ≥60 mL/min calculated as per Cockcroft-Gault equation.
* Life expectancy ≥12 weeks.
* Have recovered from the immediate post-operative period and is maintained on a stable corticosteroid regimen (no increase for 5 days) prior to initiation of study treatment.
* Female patients, of childbearing potential, must have a negative serum pregnancy test within 7 days prior to taking study medication and agree to use at least one highly effective form of contraception during study treatment and for at least 120 days after the last dose of study treatment.
* Male patients must agree to use an adequate method of contraception from enrollment through 120 days after the last dose of study treatment.

* Any prior treatment for glioblastoma, including chemotherapy, immunotherapy, targeted therapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, lymphokine-activated killer cell therapy or gene therapy), or radiotherapy. Glucocorticoid therapy is permitted.
* Second primary malignancy expected to require active treatment within a 6-month period (except basal cell or early-stage squamous cell carcinoma of the skin that may be excised). Patients who had another malignancy in the past but have been free of active disease for more than 1 year, are eligible even if under active surveillance, at the discretion of the Investigator. Adjuvant anti hormonal treatment for prior breast or prostate cancer is allowed, but no other concomitant anticancer treatment.
* Any investigational therapy (for any concomitant condition) within 28 days or within 5 half-lives of study entry (whichever is shorter).
* Use of acid-reducing agents including proton pump inhibitors and histamine-2 blockers.
* Inability to comply with protocol or study procedures.
* Women who are pregnant or breastfeeding.
* Inability to swallow oral medication or gastrointestinal disorder expected to severely affect drug absorption (e.g., short bowel syndrome).
* Ongoing bacterial, viral, or fungal infection requiring systemic therapy. Prophylactic therapy is allowed. Patients with a history of Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus infection are allowed if treated with effective anti-viral therapy that results in undetectable viral load.
* Any medical condition, which in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities, or makes the patient unsuitable for study participation.

Contacts and Locations

Study Contact

Michael P Vander Hoek

CONTACT

(240) 403-4212

m.vanderhoek@shuttlepharma.org

Tyvin Rich, MD

CONTACT

tyvinr@gmail.com

Study Locations (Sites)

Lombardi Comprehensive Cancer Center

Washington, District of Columbia, 20007

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

John Theurer Cancer Center at the Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Shuttle Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-02

Study Completion Date2027-02

Study Record Updates

Study Start Date2024-09-02

Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

radiotherapy
radiation sensitizing agent
ropidoxuridine
unmethylated MGMT promoter

Additional Relevant MeSH Terms

Glioblastoma, IDH-wildtype